Label: CVS HEMORRHOIDAL TOPICAL ANALGESIC- dibucaine ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 12, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient                                 Purpose

    Dibucaine 1%...................................... Local anesthetic

  • PURPOSE

    Use

    temporarily relives pain and itching due to hemorrhoids or other anorectal disorders

  • WARNINGS

    Warnings

    For external use only

    Allergy Alert

    • Certain persons can develop allergic reactions to ingredietns in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.
  • DO NOT USE

    Do not use

    • in or near the eyes
    • in children under 2 years of age
  • WHEN USING

    When using this product

    • do not use more than directed unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • STOP USE

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years and over: if possible, clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply externally to the affected area up to 3 or 4 times daily
    • children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    store at 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    disodium EDTA, distilled water, lanolin, mineral oil, white petrolatum

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    CVS PHARMACY, INC.

    ONE CVS DRIVE

    WOONSOCKET, RI 02895 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CVS HEMORRHOIDAL TOPICAL ANALGESIC 
    dibucaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-997
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    WATER (UNII: 059QF0KO0R)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-997-281 in 1 BOX09/12/2016
    11 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/17/2014
    Labeler - CVS Pharmacy, Inc. (062312574)
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